M/s. Emmennar Pharma Pvt. Ltd., Unit – III. · 2014. 1. 29. · M/s. Emmennar Pharma Pvt. Ltd.,...

M/s. Emmennar Pharma Pvt. Ltd., Unit – III.

Prepared by Rightsource Industrial Solutions Pvt Ltd

LIST OF CONTENTS

S. No Content Name Page No’s

1 Form -I 1-12

2 List of Products 13-14

3 List of By-products 15

4 List of Raw Materials 16-22

5 Process Description 23-51

6 Water Consumption Details 52

7 Waste water Details 53-54

8 ETP Flow Chart 55

9 Solid Waste Details 56-57

10 Stack Emission Details 58-59

11 Process Emission Details 60

12 Spent solvent Details 61

13 Pre-Feasibility Report 62-63

14 Draft TOR 64-65

15 Project Report 66-80

ENCLOSURES

16 Copy of G.Os Enclosed

17 Pollution Load Details Enclosed

18 Topo Map Enclosed

19 Site Plan Enclosed

20 Copy of CFO Enclosed

21 CFO Compliance Enclosed

22 Copy of ROC Certificate Enclosed

23 TSDF Membership Enclosed

24 Consultant Details Enclosed


Prepared by Rightsource Industrial Solutions Pvt Ltd. 1

APPENDIX-I

FORM -1

I) Basic information S.NO ITEM DETAILS

1. Name of the project/s M/s. Emmennar Pharma Pvt. Ltd., Unit – III. 2. S.No.in the schedule 5 (f) 3. Proposed capacity

/area/length/tonnage to be handled/command area/lease area/ number of wells to be drilled

Proposed production capacity - 1350. 00 MT / Month. Source of water: Bore well water.

4. New/Expansion/Modernization Expansion 5. Existing Capacity/Area etc. Existing Capacity:1350 TPM

Existing Area:15.24 Acres (61673.62 SQM) 6. Category of Project i.e.’A’ or ‘B’ A 7. Does it attract the general

condition? If yes, please specify.

NO

8. Does it attract the specific condition? If yes, please specify.

NO

9. Location Survey No: 334 & 335 Turakalakhanpur village, Hatnoora Mandal, Medak (Dt), Andhra Pradesh.

10. Nearest railway station/airport along with distance in kms.

Lingampally – 35Kms Hyderabad (Shamshabad) – 60 Kms

11. Nearest Town, City, District Headquarters along with distance in kms.

Narsapur – 10 Kms Hydearabad – 70 kms

12. Village Panchayats, Zilla Parishad, Municipal Corporation, Local Body (Complete postal addresses with telephone nos. to be given)

Village Panchayat ( Turkhalakhanapur village, Hatnoora Mandal)

13. Name of the applicant Sri KVSR SESHU KUMAR 14. Registered Address M/s. Emmennar Pharma Pvt. Ltd., Unit – III.

A-4, Industrial Estate, opp.sanathnagar police station, sanath nagar, Hyderabad-500018.

15. Address for correspondence: M/s. Emmennar Pharma Pvt. Ltd., Unit – III. Plot No.203, H.No.5-36/203,Prashanti nagar, IDA, Kukatpally, Hyderabad-500072

Name Sri KVSR SESHU KUMAR Designation (Owner/Partner/CEO) Director Address M/s. Emmennar Pharma Pvt. Ltd., Unit – III.

Plot No.203, H.No.5-36/203,Prashanti nagar, IDA, Kukatpally, Hyderabad-500072

Pin Code 500072



E-mail [email protected] [email protected]

Telephone No. 040-23075699, 40126589 Fax No. 040-23070602 16. Details of alternative sites

examined, if any. Location of these sites should be shown on a topo sheet

N.A.

17. Interlinked Projects Nil 18. Whether separate application of

interlinked project has been submitted?

N.A.

19. If Yes, date of submission N.A. 20. If no, reason N.A. 21. Whether the proposal involves

approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 972? (c) The C.R.Z Notification, 1991?

Nil

22. Whether there is any Government Order/Policy relevant/relating to the site?

G.O.Ms No.62 (Ban Notification), Dt.20/04/1999 Now it is Cleared as per G.O.Ms No.64, (Ban relaxation), Dt.25/07/2013. Enclosed

23. Forest land involved (hectares) NIL 24. Whether there is any litigation

pending against the project and/or land in which the project is propose to be setup? (a) Name of the court (b) Case No. (c) Orders/directions of the Court, if any and its relevance with the proposed project.

NIL

mailto:[email protected]�



II) Activity 1. Construction, operation or decommissioning of the Project involving actions,

which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.)

S. No Information/Checklist confirmation

Yes/No Details thereof(with approximate quantities/rates, wherever possible)with source of information data

1.1 Permanent or temporary change in land use, land cover or topography including increase in intensity of land use (with respect to local land use plan)

No

No change in land use, land cover or topography.

1.2 Clearance of existing land, vegetation and buildings?

No Existing Industry having CFE &CFO.

1.3 Creation of new land uses?

No No creation of land use.

1.4 Pre-construction investigations e.g. bore houses, soil testing?

No NA

1.5 Construction works?

No Site plan Enclosed

1.6 Demolition works? No No demolition work 1.7 Temporary sites used for

construction works or housing of construction workers?

No No temporary sites for construction works or housing construction workers.

1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations

No None

1.9 Underground works including mining or tunneling?

No Not envisaged. No Mining or Tunneling Works.

1.10 Reclamation works? No Not envisaged. No Reclamation Works 1.11 Dredging? No No Dredging Work. 1.12 Offshore structures? No No Offshore Works. 1.13 Production and manufacturing

processes? Yes Enclosed

1.14 Facilities for storage of goods or materials?

Yes Store room for all goods except for bulk solvents & high quantity liquid raw materials, which will be stored in above ground tanks.

1.15 Facilities for treatment or disposal of solid waste or liquid effluents?

Yes Flow chart for treatment of Solid waste & Liquid Effluent is Enclosed

1.16 Facilities for long term housing of operational workers?

No No housing facilities will be provided for operational workers. Most of the workers are locals and nearby villages.

1.17 New road, rail or sea traffic during construction or operation?

No Not envisaged.



1.18 New road, rail, air, waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?

No Not envisaged.

1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?

No

Not envisaged.

1.20 New or diverted transmission lines or pipelines?

No Not envisaged.

1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?

No No

1.22 Stream crossings? No No 1.23 Abstraction or transfers of

water from ground or surface waters?

Yes Water requirement will be met from the Bore well.

1.24 Changes in water bodies or the land surface affecting drainage or run-off?

No There will not be any changes in water bodies or the land surface affecting drainage or run-off

1.25 Transport of personnel or materials for construction, operation or decommissioning?

No NA

1.26 Long-term dismantling or decommissioning or restoration works?

No No dismantling or decommissioning or restoration works

1.27 Ongoing activity during decommissioning which could have an impact on the environment

No

NA

1.28 Influx of people to an area in either temporarily or permanently?

Yes Workers /Employees will be increased and the working hours are in shifts / general.

1.29 Introduction of alien species? No No Introduction of alien species 1.30 Loss of native species or

genetic diversity? No No Loss of native species or genetic

diversity 1.31 Any other actions?

No __



2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non-renewable or in short supply )


Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data

2.1 Land especially undeveloped or agricultural land (ha)

No Nil

2.2 Water (expected source & competing users) unit: KLD

Yes 178.60KLD from Bore well water.

2.3 Minerals (MT) No No Minerals required 2.4 Construction material – stone,

aggregates, sand/soil (expected source (MT)

No NA

2.5 Forests and timber (source – MT)

No No Timber will be used.

2.6 Energy including electricity and fuels (source, competing users) Unit: fuel (MT), energy (MW)

Yes • Electricity–From - APCPDCL Existing - 300 KVA

• Generator: Existing - 1000 KVA -1 No

250 KVA - 1 No Fuel: HSD about 600 Liters per day

• Steam: Boiler (Coal Fired) Existing – 1.5 TPH

In addition to the above existing, the industry proposing another Boiler – 3.0 TPH – 1 No’s

Fuel: Coal - Existing – 3.5TPD Proposed – 7.5 TPD

2.7 Any other natural resources (use appropriate standard units)

No None

3. Use, storage, transport, handling or production of substances or materials, which

could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health.


Yes/No Details thereof (with approximate quantities/rates, wherever possible)with source of information data

3.1 Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies)

Yes Enclosed. List of hazardous chemicals are used in the products.



3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases)

No Effluent will be sent to ETP-ZLD System. All solid wastes will be stored in the covered platform with leachate collection system and sent to TSDF / Authorized agencies. Process emissions will be scrubbed in the scrubbers.

3.3 Affect the welfare of people e.g. by changing living conditions?

No Not Applicable.

3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,

No None

3.5 Any other causes

No Nil

4. Production of solid wastes during construction or operation or decommissioning

(MT/month) S. No Information/Checklist

confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data

4.1 Spoil, overburden or mine wastes

No No Spoil, overburden or mine wastes

4.2 Municipal waste (domestic and or commercial wastes)

No The commercial waste from the administration building is generated and is to scrap vendors.

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

Yes Details of hazardous wastes generated from the enhanced capacities /load /are given.

4.4 Other industrial process wastes

Yes Details of the industries process wastes from the enhances capacities /load are given.

4.5 Surplus product

No Surplus production is not envisaged since production will be as per the market demand only.

4.6 Sewage sludge or other sludge from effluent treatment

Yes Domestic waste water sent to septic tank and overflow to ETP. ETP sludge generation details are given

4.7 Construction or demolition wastes

No No demolition waste will be generated.

4.8 Redundant machinery or equipment

No Not envisaged

4.9 Contaminated soils or other materials

No Not envisaged



5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No Information/Checklist



5.1 Emissions from combustion of fossil fuels from stationary or mobile sources

Yes

About 11 TPD Coal will be used in Boiler and about 600/liters/day diesel will be used in D.G. sets emission details are given.

5.2 Emissions from production processes.

Yes CO2 gas - 981.56 Kg/day from all the products.

5.3 Emissions from materials handling including storage or transport

Yes Pumps will be used for handling liquid raw materials and trolleys will be used for solid / powder type raw materials Vent condensers are provided for all storage tanks, centrifuges, catch pots.

5.4 Emissions from construction activities including plant and equipment

No It is capacity /load enhancement by replacing with higher capacity reactors to the Existing plant.

5.5 Dust or odors from handling of materials including construction materials, sewage and waste

No No construction activity taken place. Septic tank will be provided both during construction and operation of the plant. Hence no odors will be released into atmosphere.

5.6 Emissions from incineration of waste

No No incineration of waste in the site

5.7 Emissions from burning of waste in open air (e.g. slash materials, construction debris)

No No burning activity in the site. No emissions will generate

5.8 Emissions from any other sources

No None

6. Generation of Noise and Vibration, and Emissions of Light and Heat



6.1 From operation of equipment e.g. engines, ventilation plant, crushers

Yes Noise will be generated from the utilities section. Silencers will be provided for D.G. Sets.

6.2 From industrial or similar processes

Yes Noise from process utilities will be within the limits. About 56dB(A)

6.3 From construction or demolition

No No construction will taken place.

6.4 From blasting or pilling

No None, No blasting or pilling during construction.

4.10 Agricultural wastes No Not Applicable

4.11 Other solid wastes

No Details of other solid waste are given.



6.5 From construction or operational traffic

No None

6.6 From lighting or cooling systems

No Negligible.

6.7 From any other sources No Nil

7. Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea:

S. No Information/Checklist



7.1 From handling, storage, use or spillage of hazardous materials

Yes Spillages such as wastewater /solid wastes/raw material are possible and the risk of this would be limited to within the premises of the manufacturing facilitate. Precautionary measures are implementing in the existing permitted industry and will continue for spillage control and to avoid contamination of land or water from the pollutants or raw materials. Suggestions from the safety consultants will be followed to avoid the risk and prevent accidents.

7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)

Yes 4.50 KLD Domestic sewage will be sent to soak pit. Process effluent will be treated and evaporated and recycled within the plant.

7.3 By deposition of pollutants emitted to air into the land or into water

Yes Possibility of deposition of pollutants emitted to air into the land / water can’t be ruled out and the precautions taken by the industries to control such emissions by adopting the suitable controlling equipment will be provided such as Bag filters ,Scrubbers etc.

7.4 From any other sources

No Process emissions are controlled by scrubbers.

7.5 Is there a risk of long term build up of pollutants in the environment from these sources?

No Not envisaged. Industry will implement all latest pollution control equipment and will adopt them build up of pollutants in the environment from the industrial activity.



8. Risk of accidents during construction or operation of the Project, which could affect human health or the environment

S.No Information/Checklist confirmation


8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances

Yes All the safety precautions will be taken by the industry to avoid such accidents.

8.2 From any other causes

Yes Static Electricity

8.3 Could the project be affected by natural disasters causing environmental damage (e.g. floods, earthquakes, landslides, cloudburst etc)?

No Not envisaged.

9. Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality S. No Information/Checklist



9.1 Lead to development of supporting laities, ancillary development or development stimulated by the project which could have impact on the environment e.g. * Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) * Housing development * Extractive industries * Supply industries

Yes

No

No

Yes

Supporting infrastructure such as roads, power supply, waste or waste water treatment etc. may be impacts on the project activities however the impact from such activates will be limited. No roads will be laid, since plant site is well connected to road. Power supply will be obtained from public supply and there will not be any effect on the environment .Waste water generation from the process will be treated and reused, waste water treatment plant will be constructed and there will not be any impact on the environment. Not envisaged .possibility of extractive industries cannot be ruled out. Not envisaged.



* Other

No Not envisaged.

9.2 Lead to after-use of the site, which could have an impact on the environment

No Not envisaged.

9.3 Set a precedent for later developments

No Not envisaged.

9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects

No Marginal cumulative effects envisaged.

10. Environmental Sensitivity S.No Areas Name/

Identity Aerial distance (within 25 km) Proposed project location boundary

1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

No Note envisaged .There is no Eco sensitive area near the plant site.

2 Areas which are important or sensitive for ecological reasons – Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests

No Not envisaged .There is no wetland near the plant site.

3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

No Not envisaged.

4 Inland, coastal, marine or underground waters

No Nil

5 State, National boundaries

Yes State Boundaries. North: Nizamabad District, South: Hyderabad District, East: Warangal District and Nalgonda District. West: Karnataka

6 Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas

No Industry is about 20 km from National High way (NH-9) Hyderabad to Mumbai.

7 Defense installations

No No defense establishments within the area.

8 Densely populated or built-up area

No ---

http://www.veethi.com/places/andhra-pradesh-nizamabad-district-90.htm�

http://www.veethi.com/places/andhra-pradesh-hyderabad-district-98.htm�

http://www.veethi.com/places/andhra-pradesh-warangal-district-93.htm�

http://www.veethi.com/places/andhra-pradesh-nalgonda-district-95.htm�

http://www.veethi.com/places/andhra-pradesh-nalgonda-district-95.htm�

http://www.veethi.com/places/karnataka-state-12.htm�



9 Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities)

No There is no habitation /sensitive, manmade, land used within the specified distance.

10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals).

No NA

11 Areas already subjected to pollution or environmental damage. (Those where existing legal environmental standards are exceeded)

No N A

12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

No Not envisaged.


Prepared by Rightsource Industrial Solutions Pvt Ltd 13

LIST OF EXISTING PRODUCTS

S. No Product Name Quantity In Mt/Month

Quantity In Mt/Day

1 Weak Nitric acid (58%) on 100% basis

750.00 25.00

2 Concentrated Nitric acid (98%) on 100% basis

600.00 20.00

Total 1350.00 45.00



LIST OF PROPOSED PRODUCTS

S. No Product Name CAS No's Quantity In Mt/Month

Quantity In Mt/Day

1 Meta chloro nitro benzene 121-73-3 300.00 10.00 2 Meta chloro anisole 845-89-8 240.00 8.00 3 Diethyl-D(-)Tartarate 13811-71-7 60.00 2.00 4 Triphenyl phosphine 603-35-0 90.00 3.00 5 Metformin hydrochloride 657-24-9 450.00 15.00 6 Butaphosphan 17316-67-5 120.00 4.00 7 Ciprofloxacin Hydrochloride 857-21-33-1 90.00 3.00

Total 1350.00 45.00



LIST OF BY- PRODUCTS

S. No Name of the By-Product Quantity In Kg/Day

1 p-Chloro nitro benzene 1243.57 2 O-Chloro nitro benzene 1243.75 3 Hydrochloric acid (35%) 8264.25 4 Sodium hydroxide (48%) 4920.00 5 Phosphorous oxy chloride 2076.60



1. META CHLORO NITRO BENZENE

S. No Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Nitro Benzene 3903.00 9757.50 2 Chlorine 2302.00 5755.00 3 Ferric Chloride 78.00 195.00



2. META CHLORO ANISOLE



1 m-Chloro Nitro benzene 1163.00 9304.00 2 Potassium Hydroxide 413.00 3304.00 3 Sodium methoxide 398.00 3184.00 4 Toluene 2325.00 18600.00



3. DIETHYL-D (-) TARTARATE



1 D-Tartaric acid 500.00 2000.00 2 Ethanol 656.00 2624.00 3 Toluene 2400.00 9600.00 4 MDC 2000.00 8000.00 5 PTSA 60.00 240.00



4. TRIPHENYL PHOSPHINE



1 Tri phenyl phosphine Oxide 1180.00 3540.00 2 Aluminium powder 120.00 360.00

3 Phosphorus trichloride 620.00 1860.00 4 Toluene 5310.00 15930.00 5 Methanol 4500.00 13500.00



5. METFORMIN HYDROCHLORIDE



1 Dimethylamine Hcl 630.00 7560.00 2 N-Cyano guanidine 650.00 7800.00 3 Xylene 1550.00 18600.00 4 Activated carbon 2.00 24.00 5 Hyflo 2.00 24.00 6 Methanol 440.00 5280.00



6. BUTAPHOSPHAN



1 n-Butyl amine 1125.00 3750.00 2 Potassium carbonate 925.00 3083.33

3 Acetone 8200.00 27333.33 4 Hypo phosphorus acid 1470.00 4900.00 5 Acetic acid 22.50 75.00



7. CIPROFLOXACIN HYDROCHLORIDE



1 Q-Acid 1000.00 3000.00 2 Piperazine 800.00 2400.00

3 Sodium Hydroxide flakes 402.00 1206.00 4 Acetic acid 562.00 1686.00 5 Hydrochloric acid (30%) 1000.00 3000.00 6 n-Butanol 1100.00 3300.00 7 Methanol 3400.00 10200.00 8 Activated carbon 50.00 150.00



1. META CHLORO NITRO BENZENE

Process Description:

Stage-1

Nitrobenzene undergoes Chlorination in presence of Ferric chloride as a Catalyst to

give Meta Chloro Nitro Benzene as a product.



META CHLORO NITRO BENZENE

Route of Synthesis:

Stage-1

NO2

Nitro-benzene

+ Cl2

Chlorine

C6H5NO2

123.11

70.91

FeCl3

NO2

Cl

m-Chloro Nitro benzene

C6H4ClNO2

157.55

+ HCl

Hydrochloric acid

36.50




Flow Chart:


NitrobenzeneChlorine FeCl3

Stage-1 Effluent water




Material Balance:

Material Balance of Meta Chloro Nitro Benzene Stage-1

Batch Size: 4000.0 Kgs Name of the input Quantity

in Kg Name of the out put Quantity

in Kg Nitro Benzene 3903.00 Meta Chloro Nitro Benzene 4000.00 Chlorine 2302.00 Effluent water 862.00 Ferric Chloride 78.00 (Water-784,Ferric chloride-78) Water 2932.00 By products 4300.30

(P-Chloro nitrobenzene-497.43, O-Chloro nitrobenzene-497.43, Hydrochloric acid (35%)-3305.7)

Chlorine Loss 52.70 Total 9215.00 Total 9215.00



2. META CHLORO ANISOLE

Process Description

Stage-1

m-Chloro Nitro benzene Reacts with Sodium methoxide and Potassium Hydroxide in

presence of Toluene as a solvent media to give Meta Chloro Anisole as a product.



META CHLORO ANISOLE

Route of Synthesis:

Stage-1

m-Chloro Nitro benzene

C6H4ClNO2

157.55

+ KOH

Potassium Hydroxide56.11

+ CH3ONa

Sodium methoxide

54.02

Toluene

OCH3

Cl

m-Chloro Anisole

C7H7ClO

142.58

Potasium Nitrite

KNO2+

85.10

+

18-Crown-6

NaOH

40.00

Cl

NO2



META CHLORO ANISOLE

Flow Chart

Stage-1

META CHLORO ANISOLE

m-Chloro nitrobenzeneKOHMethanolToluene

Toluene RecGenerated water



META CHLORO ANISOLE

Material Balance

Material Balance of Meta Chloro Anisole Stage-1



in Kg m-Chloro Nitro benzene 1163.00 Meta Chloro Anisole 1000.00 Potassium Hydroxide 413.00 Toluene Recovery 2253.00 Sodium methoxide 398.00 Toluene Loss 70.00 Toluene 2325.00 Inorganic solid waste 627.00 Water 2326.00 (Potassium Nitrite) Organic Residue 52.00 (Organic impurities-51,

Toluene-1)

By-Product 615.00 (48 %Sodium hydroxide) Effluent water 2008.00 (Water-2007,Toluene-1) Total 6625.00 Total 6625.00



3. DIETHYL-D (-) TARTARATE


Stage-1

D-Tartaric acid reacts with Ethanol in presence of PTSA as a Catalyst and Toluene

as a solvent media to give Diethyl-D (-) Tartarate as a product.



DIETHYL-D (-) TARTARATE

Route of Synthesis:

Stage-1

D-Tartaric acid

OH

OHO

HO

O

OH

C4H6O6

150.09

+

Ethanol

2 C2H5OH

2X40.07=80.14

PTSA

TolueneH3C O

O CH3

O

OOH

OH

Di Ethyl D(-) Tartarate

C8H14O6

206.19

+ 2 H2O

2X18=36.00




Flow Chart

Stage-1Toluene RecMDC RecEffluent water


D(-)Tartaric AcidPTSAToluene EthanolMDC




Material Balance:

Material Balance of Diethyl-D(-) Tartarate Stage-1



in Kg D-Tartaric acid 500.00 Diethyl-D(-) Tartarate 500.00 Ethanol 656.00 Ethanol Recovery 369.00 Toluene 2400.00 Ethanol Loss 19.00 MDC 2000.00 Toluene Recovery 2327.00 PTSA 60.00 Toluene Loss 72.00 Water 800.00 MDC Recovery 1939.00 MDC Loss 60.00 Effluent water 982.00 (Water-800,PTSA-60,

Generated water-120, Toluene-1,Ethanol-1)

Organic Residue 148.00 (Organic impurities-147,MDC-1) Total 6416.00 Total 6416.00



4. TRIPHENYL PHOSPHINE


Stage-1

Triphenyl phosphine oxide reacts with Phosphorus trichloride in the presence of Al

powder as catalyst and Toluene as a solvent media to give Triphenyl Phosphine as

product.



TRIPHENYL PHOSPHINE

Route of Synthesis:

Stage-1:

Triphenyl phosphine Oxide

P O+ P

Cl

Cl Cl

Phosphorus Trichloride

C18H15OP

278.28

137.33

Al Powder

Toluene

Triphenyl phosphine

P

C18H15P

262.29

+ POCl3

153.33

Phosphorus oxy chloride



TRIPHENYL PHOSPHINE

Flow Chart:

Stage-1

TRIPHENYL PHOSPHINE

Triphenyl phosphine oxidePCl3TolueneMethanol

Toluene RecMethanol RecPhosphorus oxychloride



TRIPHENYL PHOSPHINE

Material Balance:

Material Balance of Triphenyl phosphine Stage-1

Batch Size: 1000.0Kgs Name of the input Quantity


in Kg Tri phenyl phosphine Oxide 1180.00 Triphenyl phosphine 1000.00 Aluminium powder 120.00 Methanol Recovery 4363.00 Phosphorus trichloride 620.00 Methanol Loss 135.00 Toluene 5310.00 Toluene Recovery 5149.00 Methanol 4500.00 Toluene Loss 160.00 Water 5290.00 Effluent water 5292.00 (Water-5290, Methanol-1,

Toluene-1)

Organic Residue 228.80 (Organic Impurities-226.8 ,

Methanol-2)

By-product 692.20 (Phosphorus oxy chloride) Total 17020.00 Total 17020.00



5. METFORMIN HYDROCHLORIDE


Dimethylamine hydrochloride reacts with Dicyanodiamide in the presence of Xylene

and Water Solvent media to produce aqueous layer containing Metformin

Hydrochloride which is purified with Activated carbon in the presence of Methanol

Solvent media to produce Metformin Hydrochloride.



METFORMIN HYDROCHLORIDE

Route of Synthesis:

Stage-1

HN

CH3H3C

C2H8NCl

81.58

+ H2N NH

CN

NH

N-Cyanoguanidine

C2H4N4

84.08

Dimethyl amine Hydrochloride

HCl

NH3C

CH3

HN NH2

NH NH

HCl

Metformin HydrochlorideC4H12N5Cl

165.66

Xylene




Flow Chart:

Stage - 1

Dimethylamine HclN-Cyano guanidineXyleneMethanol

Xylene RecoveryMethanol Recovery

Metformin Hydrochloride




Material Balance:

Material Balance of Metformin Hydrochloride Stage-1

Batch Size: 1250Kg Name of the input Quantity


in Kg Dimethylamine Hcl 630.00 Metformin Hydrochloride 1250.00 N-Cyano guanidine 650.00 Xylene Recovery 1500.00 Xylene 1550.00 Xylene Loss 50.00 Activated carbon 2.00 Methanol Recovery 410.00 Hyflo 2.00 Methanol Loss 22.00 Methanol 440.00 Effluent water 1315.00 Water 1300.00 (Water-1300,Methanol-5,Dimethyl

Amine Hydrochloride-10)

Spent carbon + Hyflo 4.00 Organic Residue 23.00 (Organic Impurities-20,

Methanol-3)

Total 4574.00 Total 4574.00



6. BUTAPHOSPHAN


Stage-1

Acetone reacts with n-Butyl amine in the presence of Potassium carbonate as base

to give schiff’s base and further treated it with Hypo phosphorus acid in the

presence of Acetone as a solvent media and undergoes purification with n-

Propanol to give Butaphosphan as product.



BUTAPHOSPHAN

Route of Synthesis:

Stage-1:

Step-A

Acetone

H3C

O

CH3

C3H6O

58.08

+

n-Butyl amine

H2N CH3

C4H11N

73.14

+ K2CO3

138.21

Potassium carbonate

H3C

H3C

N CH3

Butyl-isopropylidene-amine

C7H15N

113.20

+ 2 KOH

Potassium hydroxide

2X56.11=112.22

+ CO2

Carbon dioxide

44.00



Step-B

H3C

H3C

N CH3

Butyl-isopropylidene-amine

C7H15N

113.20

+

Hypophosphorus acid

P

O

HHO

H

H3PO2

66.00

Acetone

HO P

O

H

C

CH3

CH3

NH

CH3

Butaphosphan

C7H18NO2P

179.20



BUTAPHOSPHAN

Flow Chart:

Stage-1

Acetonen-Butyl aminePotassium carbonateHypophosphoric acidn-Propanol

n-Butanol RecCarbon dioxide

BUTAPHOSPHAN



BUTAPHOSPHAN

Material Balance:

Material Balance Of Butaphosphan Stage-1

Batch Size: 1200 Kgs Name of the input Quantity


in Kg n-Butyl amine 1125.00 Butaphosphan 1200.00 Potassium carbonate 925.00 Acetone Recovery 7788.00 Acetone 8200.00 Acetone Loss 410.00 Hypo phosphorus acid 1470.00 Potassium hydroxide

Recovery 1419.24

Acetic acid 22.50 Process Emission 294.47 (Carbon dioxide) Organic Residue 630.79 (Organic impurities-628.79,

Acetone-2)

Total 11742.50 Total 11742.50



7. CIPROFLOXACIN HYDROCHLORIDE

Process description:

Stage-1

Q-Acid reacts with Piperazine in presence of n-Butanol and Methanol as a solvent

media to give Ciprofloxacin Hydrochloride as a product.



CIPROFLOXACIN HYDROCHLORIDE

Route of Synthesis

Stage-1

N

O

F

Cl

COOH

Q-Acid

C13H9ClFNO3

281.67

Piperazine

NH

HN

+

C4H10N2

86.14

+ HCl

Hydrochloric acid

36.5

Acetic acid

CH3COOH

C2H4O2

60.05

+ + 2 NaOH

Sodium Hydroxide

2X40.00=80.00

Methanol

N

O

F

N

COOH

HN

HCl

Ciprofloxacin Hydrochloride

C17H19ClFN3O3

367.80

+ CH3COONa

Sodium acetate

82.03

C2H3O2Na

+ 2 H2O

2X18=36.00

NaCl

Sodium chloride

58.44

+




Flow Chart

Stage-1

Q- ACIDPiperzinesodium hydroxide flakesAcetic acidHCl n- ButanolMethanol


n-Butanol RecMethanol RecEffluent water




Material Balance:

Material Balance of Ciprofloxacin Hydrochloride Stage-1



in Kg Q-Acid 1000.00 Ciprofloxacin Hydrochloride 1000.00 Piperazine 800.00 n-Butanol Recovery 1067.00 Sodium Hydroxide flakes 402.00 n-Butanol Loss 33.00 Acetic acid 562.00 Methanol Recovery 3295.00 Hydrochloric acid (30%) 1000.00 Methanol Loss 102.00 n-Butanol 1100.00 Piperazine Recovery 500.00 Methanol 3400.00 Effluent water 4544.90 Activated carbon 50.00 (Water-3000,Generated water-

180.9,Water from Hydrochloric acid-300,Sodium acetate-768, Sodium Chloride-294, Methanol-2)

Water 3000.00 Spent Carbon 50.00 Organic Residue 722.10

(Organic impurities-721.1, Methanol-1)

Total 11314.00 Total 11314.00



WATER REQIREMENT DETAILS

S. No Purpose Water Requirement In KLD

1 Process 69.60 2 Washings 4.00 3 Boiler make up 30.00 4 Cooling towers Make up 56.00 5 DM Plant Regeneration 3.00 6 Scrubbing system 1.00 7 Domestic 5.00 8 Gardening 10.00 Total 178.60



WASTE WATER DETAILS

S. No Purpose Effluent Generation

In KLD 1 Process 67.43 2 Washings 4.00 3 Boiler Blow down 4.00 4 Cooling towers Blow down 10.00 5 Scrubbing system 1.00 6 DM Plant 3.00 7 Domestic 4.50

Total 93.93



HTDS & LTDS DETAILS

Unit HTDS KLD

LTDS KLD

Effluent Generation

in KLD

Treatment Method

Process

51.37 16.06 67.43 HTDS Effluent sent to MEE system and Condensate to ETP. LTDS effluents treated in ETP – RO Plant / RO Rejects to MEE System and RO permeate to reuse, Condensate from MEE to reuse and MEE residue to ATFD.

Washings 0.00 4.00 4.00 Boiler Blow Down

4.00 0.00 4.00

Cooling towers Blow Down

0.00 10.00 10.00

Scrubber System

1.00 0.00 1.00

DM Plant 3.00 0.00 3.00

Domestic

0.00 4.50 4.50 Septic tank followed by soak pit

Total 59.37 34.56 93.93


Prepared by Rightsource Industrial Solutions Pvt. Ltd 55

FLOW CHART FOR EFFLUENT TREATMENT

Effluent Type

Treatment Flow

HTDS/HCOD Collection Equalization & neutralization Stripper MEE ATFD TSDF MEE Condensate will be Reused.

HTDS Collection Equalization & neutralization MEE ATFD TSDF MEE Condensate will be Reused.

LTDS/LCOD Collection ETP (Biological Treatment) Sand Filter Carbon Filter Booster pump to Membrane Filter set RO Plant RO Reject to MEE RO Permeate to Reused.



SOLID WASTE DETAILS

S. No Name of the Solid Waste Quantity In Kg/Day

Disposal Method

1 Organic solid waste 3412.00 Sent to Cement Industries 2 Inorganic solid waste 5016.00 Sent to TSDF 3 Spent carbon 198.00 Sent to Cement Industries 4 Evaporation salts 6082.60 Sent to TSDF 5 ETP Sludge 50.00 Sent to TSDF 6 Distillation bottom Residue 15.00 Sent to Cement industries 7 Boiler Ash 5500 Sent to Brick Manufactures



HAZARDOUS WASTE DETAILS

S. No Description Quantity Mode of Disposal

1 Waste Oils 1200 Litres/Annum Sent to TSDF, Dundigal, R.R Dist for incineration/Authorised cement Industries for Co-processing.

2 Used Lead acid Batteries 6 No's / 2 Annum Sent to Authorised Reprocessors/Recyclers

3 Containers & Container liners of Hazardous waste and chemicals

250 Drums /Month After detoxification, it should be disposed to the outside agencies.



STACK EMISSION DETAILS FOR BOILER

Particulars Units 1.5 TPH Coal fired Boiler (Existing)

3.0 TPH Coal fired Boiler (Proposed)

Type of Fuel -- Indian Coal Indian Coal

Coal Consumption TPD 3.5 7.5

Ash Content % 47 47

Sulphur Content % 0.8 0.8

Nitrogen Content % 1.07 1.07

No. of Stacks No 1 1

Height of Stack M 30 30

Diameter of Stack M 0.60 0.60

Temperature of Flue Gas oC 95 100

Velocity of Flue Gas m/s 6.5 7.5

Particulate Matter at outlet

of Bag filter (Based on 115

mg/Nm3 at outlet)

gm/sec 0.21 0.24

Sulphur dioxide emission gm/sec 0.46 0.69

Oxides of Nitrogen emission gm/sec 0.57 0.93

The Industry has 0.6TPH Waste Heat Recovery Boiler as Standby.



STACK EMISSIONS FOR DG SETS

Capacity In KVA

Emission of SPM

in mg/NM3

Emission Of SO2

in mg/NM3

Emission of NOx

in mg/NM3

Stack dia. In m

Flue Gas

Temp. in OC

Stack Height in (m)

Flue gas Velocity In m/sec.

250 KVA

65.0 110.0 135.0 0.30 290 8 18.50

1000KVA 160.0 380.0 470.0 0.30 290 10 46.40



PROCESS EMISSION DETAILS

S. No Name of the Gas Quantity In Kg/Day

Disposal Method

1 Carbon dioxide

981.56 Dispersed Into Atmosphere



SPENT SOLVENT DETAILS

S. No Name of the product Name of the solvent

Solvent Recovery

In Kg/Batch

Solvent Recovery In Kg/day

1 Meta Chloro Anisole Toluene 2253.00 18024.00 2 Diethyl-D (-) Tartarate Ethanol 369.00 1476.00 Toluene 2327.00 9308.00 MDC 1939.00 7756.00

3 Triphenyl Phosphine Methanol 4363.00 13089.00 Toluene 5149.00 15447.00

4 Metformin Hydrochloride Xylene 1500.00 18000.00 Methanol 410.00 4920.00

5 Butaphosphan Acetone 7788.00 25960.00 Ciprofloxacin Hydrochloride n-Butanol 1067.00 3201.00 Methanol 3295.00 9885.00 Total 30460.00 127066.00



PRE FEASIBILITY REPORT

1. Executive Summary NA 2. Introduction of the project/ Background information. - (i) Identification of project and project proponent.

In case of mining project, a copy of mining Lease/ letter of intent should be given.

NA

(ii) Brief description of nature of the project. Bulk Drug & Intermediates manufacturing

(iii) Need for the project and its importance to the country and or region

Enclosed

(iv) Demand-Supply Gap. - (v) Imports vs. Indigenous production. - (vi) Export Possibility. Yes (vii) Domestic / export Markets. Yes (viii) Employment Generation (Direct and Indirect) due to the

project. DIRECT- 100 INDIRECT-100

3. Project Description (i) Type of project including interlinked and

interdependent projects, if any Bulk Drug & Intermediates manufacturing

(ii) Location (map showing general location, specific location, and project boundary & Project site layout) with coordinates.

Enclosed

(iii) Details of alternate sites considered and the basis of selecting the proposed site, particularly the environmental considerations Gone into should be highlighted.

--

(iv) Size or magnitude of operation. Small Scale Industry(SSI) (v) Project description with process details (a schematic

diagram/ flow chart showing the Project layout, components of the project etc. should be given)

Enclosed

(vi) Raw material required along with estimated quantity, likely source, marketing area of final product/ s, Mode of transport of raw Material And Finished Product.

Enclosed

(vii) Resource optimization/ recycling and reuse envisaged in the project, if any, should be Briefly outlined.

NA

(viii) Availability of water its source, Energy/ power Requirement and source should be given.

Bore well water

(ix) Quantity of wastes to be generated (liquid and solid) and scheme for their Management/disposal.

---

(x) Schematic representations of the feasibility Drawing which give information of EIA purpose.

NA

4. Site Analysis (i) Connectivity. National High way(NH-9)

Hyderabad -Mumbai (ii) Land Form, Land use and Land ownership. Dry Land (iii) Topography (along with map). Yes (iv) Existing land use pattern (agriculture, non agriculture,

forest, water bodies (including area under CRZ) ), shortest distances from the

Dry Land



periphery of the project to periphery of the forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from the HFL of the river), CRZ. In case of notified industrial area, a copy of the Gazette Notification should be given.

(v) Existing Infrastructure. Dry Land (vi) Soil classification Mixed Soil (vii) Climatic data form secondary sources. Will be submitted in EIA

Report (viii) Social Infrastructure available. -- 5. Planning Brief (i)

Planning Concept (type of industries, facilities, transportation etc) Town and Country Planning/ Development authority Classification.

NA

(ii) Population Projection (iii) Land use planning (breakup along with green belt etc). (iv) Assessment of Infrastructure Demand (Physical &

Social).

(v) Amenities /Facilities. 6. Proposed Infrastructure (i) Industrial Area (Processing Area). -- (ii) Residential Area (Non Processing Area). --- (iii) Green Belt. 5.02 Acres ( 20351 Sq. Mts) (iv) Social Infrastructure. --- (v) Connectivity (Traffic and Transportation Road/ Rail/

Metro/ Water ways etc) National High way(NH-9) Hyderabad -Mumbai

(vi) Drinking Water Management (Source & Supply of water)

Bore well water

(vii) Sewerage System. Septic tank flowed by soak pit

(viii) Industrial Waste Management. MEE System in Plant (ix) Solid Waste Management. TSDF, Dundigal village,

Quthbullapur(M), Rangareddy(Dt.)

(x) Power Requirement & Supply / source. APSPDCL- 300 KVA 7. Rehabilitation and Resettlement (R & R) Plan (i) Policy to be adopted (Central/ State) in respect of

the project affected persons including home oustees, land oustees and landless laborers (a brief outline to be given)

NA

8. Project Schedule & Cost Estimates (i) Likely date of start of construction and likely date of

completion ( Time schedule for the Project to be given).

-----

(ii) Estimated project cost along with analysis in Terms of economic viability of the project.

9.113 crores

9. Analysis of proposal (Final Recommendations) (i) Financial and social benefits with special emphasis

on the benefit to the local people Including tribal population, if any, in the area.

These types of industries will contribute in development of local villagers because of employment to the locals.



Proposed Draft Terms of Reference for Preparation of EIA & EMP For M/s. Emmennar Pharma Pvt. Ltd., Unit – III.

01. Executive summary of the project 02. Justification of the project 03. Promoters and their back ground 04. Regulatory framework 05. A map indicating location of the project and distance from severely polluted areas 06. Project site location along with site map of 10 km area and site details providing various industries, surface water bodies, forests etc. 07. A copy of Gazette Notification issued by the Govt. of Andhra Pradesh indicating location of the project in Notified Industrial Area 08. Plant Layout 09. Infrastructure facilities including power sources 10. Total cost of the project along with total capital cost and recurring costs environmental pollution control measures 11. Present land use based on satellite imagery for the study area of 10 km radius. 12. Details of the total land and break-up of the land use for green belt and other uses 13. Location of National Park/Wild life sanctuary/Reserve Forest within 10 km radius of the project 14. List of products along with the production capacities 15. Maximum number of products and its production capacity to be manufactured at a time (worst-case scenario) 16. Detailed list of raw material required and source, mode of storage and transportation. 17. Explore the use of solvent other than benzene 18. Manufacturing process details along with the chemical reactions and process flow chart. 19. Site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall is necessary 20. Ambient air quality monitoring at 6 locations within the study area of 10 km., aerial coverage from project site 21. One season site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall and AAQ data (excluding monsoon season) for PM2.5, PM10, SO2, NOx and VOCs including 22. The monitoring stations should take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. Data for water and noise monitoring should also be included 23. Air pollution control measures proposed for the effective control of gaseous emissions within permissible limits. Multicyclone followed by bag filter to be provided to boiler to control particulate emissions 24. Name of all solvents to be used in the process and details of solvent recovery system. 25. Design details of ETP, incinerator, boiler, and scrubbers/bag filters etc. 26. Details of water and air pollution and its mitigation plan 27. An action plan to control and monitor secondary fugitive emissions from all the Sources



28. Determination of atmospheric inversion level at the project site and assessment of ground level concentration of pollutants from the stack emission based on Site-specific meteorological features 29. Air quality modelling for proposed plant 30. Action plan for Zero Liquid Discharge of effluent should be included. Segregation of the Wastewater should be based on the pollution load and high TDS effluent should be treated in MEE 31. Ground water quality monitoring minimum at 6 locations should be carried out. 32. Geological features and Geo-hydrological status of the study area and ecological status (Terrestrial and Aquatic) 33. The details of solid and hazardous wastes generation, storage, utilization and disposal particularly related to the hazardous waste calorific value of hazardous waste and detailed characteristic of the hazardous waste. Action plan for the disposal of fly ash generated from boiler should be included 34. Precautions to be taken during storage and transportation of hazardous chemicals should be clearly mentioned and incorporated 35. Membership for the disposal of liquid effluent in CETP or Zero Liquid discharge action plan and solid/hazardous waste in TSDF 36. An action plan to develop green belt in 33 % area 37. Occupational health of the workers needs elaboration including evaluation of Noise, heat, illumination, dust, any other chemicals, metals being suspected in Environment and going into body of workers either through inhalation, ingestion or through skin absorption and steps taken to avoid musculo-skeletal disorders (MSD), backache pain in minor and major joints, fatigue etc. Occupational Hazards specific pre-placement and periodical monitoring should be carried out 38. Socio-economic development activities should be in place 39. Note on compliance to the recommendations mentioned in the CREP guidelines 40. Detailed Environment management Plan (EMP) with specific reference to details of air pollution control system, wastewater management, monitoring frequency, responsibility and time bound implementation plan for mitigation measure should be provided 41. Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof 42. A tabular chart with index for point wise compliance of above TORs

M/S. EMMENNAR PHARMA PVT. LTD., UNIT – III.

66

PROJECT REPORT

ON MANUFACTURE OF

BULK DRUGS AND INTERMEDIATES


REGISTERED OFFICE

M/S. EMMENNAR PHARMA PVT. LTD., UNIT – III. A-4 Industrial Estate, Opposite Sanathnagar,

PoliceStation, Sanathnagar Hyderabad - 500018. Andhra Pradesh

INDIA


67

CONTENTS

A. Glimpse

B. Brief Details of the Project

C. About Promoters & group concern

D. Product Description

E. Market Survey

F. Infrastructure facilities

G. Technical Know-How

H. Selling and Marketing Arrangement.

I. Swot Analysis

J. Risk factors and mitigation

K. Proposed Layout of Plant


68

G L I M P S E

Name of the Unit : M/S. EMMENNAR PHARMA PVT. LTD., UNIT – III. Constitution : PRIVATE LIMITED .

Proposed Location of Unit : Survey No: - 334&335 Turkhalakhanapur Village Hatnoora Mandal, Medak (Dt), Andhra Pradesh.

Corporate Office : M/s. EMMENNAR PHARMA PVT. LTD., UNIT - III A-4, Industrial Estate

Oppsite Sanathnagar Police Station Sanathnagar, Hyderabad - 500 018.

Line of Activity : Manufacturing of Bulk Drugs&Intermediates . Installed Capacity : 1350 TPM Managing Director : M.Narayana Reddy Director : M. Maha Vishnu Director : K.V.S.R.Seshu Kumar Director : L.D. Maheshwara Reddy


69

Brief Details of the Project: M/S. EMMENNAR PHARMA PVT. LTD., UNIT – III. Is incorporated by technocrats

of varied experience, with the main object of producing Bulk drug, Bulk drug

intermediates for MNCs, with its registered Office situated in Hyderabad, considered

as capital of Drugs and Pharmaceutical companies in India. The Company owned

15.24 acres of land in 334 & 335, Turkhalakhanapur Village, Hatnoora Mandal,

Medak (District), Andhra Pradesh. We do not require any further acquisition of land

for the proposed products. We are planning to manufacture the same in the existing

land and infrastructure.

The company is planning to set-up in house R & D facility to develop new products.

The plant is designed for production of any product at any time, depending upon

prevailing demand, without making any major alteration to the equipment.

Land & Site development: The Company had 15.24 acres of land in 334 & 335, Turkhalakhanapur Village,

Hatnoora Mandal, Medak (Dt), Andhra Pradesh. Out of the 61671 Square Meters of

land, the company proposes to utilize around 41000 Sq. Mts of land towards

establishing the manufacturing facilities, administrative block, utilities and storage

areas including future expansion. The company has allocated the balance area of

20351 Sq. Mts for green-belt development.

Plant & Machinery:

All the Plant and Machinery required for the proposed project would be procured

indigenously and the Cost for the equipment is around 911.33 Lakhs.

Furniture fixtures and other Assets: The furniture and fixture proposed to be purchased include production furniture,

fixture involving production tables, workers stools, office cabinets and racks,

executive tables, chairs, office filling cabinets. Vehicles will be purchased for

facilitating movements or workers and materials.


70

Implementation Schedule:

Activity Time frame for completion

Acquisition of land and development

In the existing premises

Construction of factory buildings

In the existing facility only.

Plant and Machinery. Process Equipment

-

Existing Plant &Machinery

-

- Commercial Production August-2009

Preliminary and preoperative expenses: Preliminary and preoperative expenses are estimated at Rs. 20.0 lacs from the start

up time of this project till the commencement of commercial production. The

expenses include Rents, travel cost, salary and wages, legal and professional

charges and interest during the construction period. The cost also includes the

expenses incurred in the production trial runs before commencement of commercial

production.

THE PROMOTERS:

Mr. M.Narayana Reddy, Founder and MANAGING DIRECTOR of M/s. EMMENNAR

PHARMA PVT LTD, UNIT - III who is having vast experience in Pharma sector for

more than 40 years and he served Pharma Industry in Hyderabad in different

positions (Ex President of BDMA). He is a Post Graduate in Organic Chemistry and

is having much experience in Organic Synthesis. He developed

“SULPHAMETHOXAZLE” and now he is the only producer in world, Today CHINA

kept Anti Dumping Duty on our Product, but even today, he is exporting the same

product to CHINA Market.


71

Mr. M. Maha Vishnu, DIRECTOR graduated in B. Tech (Chemical Engineering) and

pursued his MBA in Marketing Management in USA. He involved along with his

Dean submitted their thesis on “UTILIZATION & MINIMISATION OF INDUSTRIAL

WASTE – FOR INFRASTRUCTURE DEVELOPMENT”

Mr. K.V.S.R, SeshuKumar, with Post Graduate in Chemistry, has work experience of

more than 20 years in different Bulk Drug industries. He is having vast experience in

Research & Development segment and at present he is officiating as DIRECTOR of

the Company.

Mr. L.D.Maheshwara Reddy had completed his M. Tech (Chemical Engineering)

from IIT, Kanpur and he has work experience of more than 20 years in Project

Development, Production & Planning in different Bulk Drug industries.

PRODUCT DESCRIPTION

Intermediates which are the active ingredients with medicinal properties and are the

best raw materials for making Bulk Drugs and Formulations which are specific

dosage forms of a Bulk Drug or of a combination of different Bulk Drugs and the final

form in which the drugs are sold i.e. syrups, injections, tablets, and capsules.

The Company proposes to manufacture the following products and their intermediates.

1. Meta Nitro Chloro Benzene : 300 MT/Month 2. Meta Chloro Anisole : 240 MT/Month 3. Diethyl D (-) Tartarate : 60 MT/Month. 4. Recovery of Triphenyl Phosphine : 90 MT/Month 5. Para Methoxy Benzyl Alcohol : 210 MT/Month 6. Tramadol Hydrochloride : 240 MT/Month 7. Ciprofloxacin Hydrochloride : 210 MT/Month.


72

MARKET SURVEY The field of Bulk Drugs and intermediated is broad-based. It covers all products and

preparations used in the production of pharmaceutical formulations. The bulk drugs

industry segment in India has been able to establish its presence in the international

markets and more than 60 percent of its produce is exported. This segment has

managed tremendous growth, with production of only Rs. 0.18 billion in 1960, rising

to Rs. 10.0 billion by 2005 and hence meeting 70 percent of the domestic

requirement. The segment is a net foreign exchange earner producing export quality

drugs; with bulk drugs export accounting for 60 percent of the total pharma industry

exports. Exports of bulk drugs are growing by 30 percent per year. But given the size

of the world market,

Supply from India is miniscule – India’s exports account for only 1.0 percent of the

worldwide demand. In terms of the inputs used in production of drugs the industry

faces low cost of inputs at competitive rates helped by the presence of a well

developed chemical industry.

As the manufacture of most bulk drugs is neither capital intensive nor technology

intensive, process re-engineering encouraged the growth of production bases. There

are a large number of bulk drug manufacturers in India, including many small scale

industries. This has increased competition, leading to a drop in prices and

consequently lower margins. Most bulk drugs under the DPCO sell below the

government administered prices due to stiff competition and lower import tariffs.

PHARMACEUTICAL INDUSTRY – GLOBAL SCENARIO As per IMS Retail Drug Monitor, sales through pharmacies in thirteen leading

markets for the year to August 2003 are $ 298.7 Billion. According to the IMS World

Review, in 2004, global audited sales of pharmaceuticals rose 8% (at a constant

dollar rate) to reach US $ 400.6 Billion. IMS world Review tracks actual sales of

approximately 90% of all prescription drugs and certain over-the-counter (OTC)

products in more than 70 countries. Using proprietor data projection methodologies

to estimate total global pharmaceuticals sales, which grew to US $ 430.3 Billion in

2005. Despite economic challenges in the worlds leading markets and a lower-than-

normal number of new product introductions, the global pharmaceutical industry

experienced good growth in 2005.


73

PHARMACEUTICAL INDUSTRY – DOMESTIC SCENARIO The Indian Pharmaceutical Industry today is in the front rank of India’s Science-

based industries with wide ranging capabilities in the complex field of drug

manufacture and technology. The Indian Pharmaceutical industry is estimated to be

worth US $ 8.0 billions at present, growing at a CAGR of over 15 % annually. If

India‘ s high Economic growth rate holds steady, the pharmaceuticals market will

triple to $ 24 billion by 2015 and become one of the world` s top 10 markets

according to a study by McKinsey and company ,a leading management

consulting firm. At a compounded annual growth rate of 15.0 %, the absolute

growth of $ 24 billion will be next to the growth potential of the US and China, and in

the same league as the growth in Japan and Canada and the UK. Five factors will

drive the growth of the Indian Pharmaceuticals market over the next decade;

Doubling of disposable incomes and the increase in numbers of middle class

households , significant expansion of medical infrastructure, greater penetration of

health insurance, a gradual shift in disease profile and adoption of patented

products, and finally population growth.

It ranks very high in the third world, in terms of technology, quality and range of

medicines manufactured. Playing a key role in promoting and sustaining

development in the vital field of medicines, the Indian Pharmaceutical Industry

boasts of quality producers and many units approved by regulatory authorities in

USA and UK. Internationally Companies associated with this sector have stimulated,

assisted and spearheaded this dynamic development in the past 50 years and

helped to put India on the pharmaceutical map of the world.

The Indian Pharmaceutical sector has more than 20,000 registered units. It has

expanded drastically in the last two decades. The leading 250 pharmaceutical

Companies control 70% of the market. The pharmaceutical industry in India meets

Around 70% of the country’s demand for bulk drugs, drugs intermediates,

pharmaceutical formulations, chemicals, tablets, capsules, orals and injectables.

There are about 250 large units and about 8000 small Scale Units, which form the

core of the pharmaceutical industry in India (including 5 Central Public Sector Units).

These units produce the complete range of pharmaceutical formulations, i.e.


74

medicines ready for consumption by patients and about 350 bulk drugs, i.e.

chemicals having therapeutic value and used for production of pharmaceutical

formulations.

PHARMACEUTICAL INDUSTRY – HYDERABAD SCENARIO Hyderabad has emerged as major drug manufacture city with a presence in global

market. Pharma industry in the state contribute more than one third to the country’s

total production. During 2005-06, the State produced bulk drugs and formulations

worth US $ 2.5 billion.

The exports from the state stood at US $ 1.0 billion in 2004-05 registering an annual

growth of more than 20%. The sector accounts for about 20 % of the total exports

from state.

Most of the companies have set up their R&D facilities in the state, thus making the

state the pharmaceutical capital of the country.

Hyderabad has developed as a major production center for bulk drugs due to the

location of many major Pharmaceutical Industries such as Dr. Reddy’s Laboratories,

Aurobindo Pharma, Neuland Laboratories, Siris, Hetero Drugs, Divis Labs, Natco

Pharma Limited, Matrix Labs, Nicholas Piramal etc., besides a large number of

medium and small industries manufacturing bulk drugs of all kinds. In support of this growth in Hyderabad and Bangalore, many basic chemical units

and drug intermediate units have also come up to meet the input requirements of

Bulk Drug manufacturing Companies. Large numbers of these units are still

dependent on supply of basic chemicals mainly from Mumbai, Gujarat and other

parts of the country involving heavy expenditure on transport and transit risks.

So, considering the above factors, it is assured that setting up of basic drug

intermediate unit near Hyderabad will be of better prospect as we can meet the

needs of the Bulk Drug units located in and around Hyderabad. The products can be

supplied to the bulk consumers speedily and at lower prices reducing transport cost

and time and transit risks. The products can also be exported easily of proper

marketing tie-ups are made with the overseas bulk drug manufacturers in the due

course as there is good export potential for the basic drugs and intermediates.


75

UTILITIES a) Power Requirement of power and its arrangements: The company is having 300 KVA CMD power connections and it requires 1000 KVA

for the proposed project from state electricity board. The company is having 250

KVA &1000 KVA DG sets.

b) Water Requirement of Water The unit requires about 178.60 KLD of water per day for process and other uses.

The area has good ground water source and the required amount of water can be

obtained by Bore well.

C) Boiler: The company proposes to install 3MT/Hr coal fired boiler. The company is having 1.5

TPH Coal Fired Boiler & 0.6 TPH waste heat recovery boiler. In addition to this we

are proposing to install 3 TPH Boiler to meet the additional quantity of steam

specially for VAM and for Forced Evaporation system.

D) Man power: The man power requirement of project is as under:

Particulars No. of employees

Functional Area

Key managerial staff 5 Finance, Marketing, Production, Quality control, R&D, Logistics etc.

Administration 5 Office work Skilled and semi skilled

40 Production Process, Maintenance, stores, Safety.&Un skilled workers

Un skilled 50 Production Process, Maintenance, stores, Safety & Unskilled workers

Total 100

Qualified and Skilled man power is available in and around Hyderabad both on

permanent and temporary basis. We can also utilize services of experts on ad-hoc

basis for production of specialty products.


76

The company is planning to have good team of employees in all areas. Looking in to

long term planning, company will take all the necessary steps to develop a good

team of work force. The company will provide all basic amenities to staff such as

Medical Health, children education, transport, canteen facility, transport, clothing,

financial assistance, family welfare etc.

The company will organize training classes for all the staff in the areas of Process up

gradation, Quality control, cost reduction techniques, safety etc.

E) EFFLUENT (WASTE WATER), SOLID WASTE TREATMENT & DISPOSAL:

The industry shall adopt and follow an environmental management plan for

abatement of pollution and overall enhancement of the quality of environment in and

around the unit.

About 93.93 KL / day of effluent (wastewater) is generated from process and utilities.

The Company proposes to have a full pledged Effluent Treatment Plant (ETP) to

treat the effluent as per the norms.

Part of the treated effluent would be recycled and used for the process.

Part of treated effluent is sent for forced evaporation for final treatment. The residue

collected from forced evaporation and solid waste would be stored in HDPE

drums/Bags and disposed to TSDF facility.

e) GREEN BELT DEVELOPMENT: Green belt with selected perennial plant species developed in all around the site.

This is to be considered as an essential requirement against pollution though it may

add to the initial costs of the project. The green belt is considered essential because

of the following:

• Plants act as pollutant sinks

• Green belt helps in noise attenuation

• Green belt balances ambient oxygen and carbon dioxide levels

• Green belt leads to a significant drop in air temperature near the

manufacturing shed.


77

TECHINCAL KNOW-HOW The process of manufacturing Bulk drug Intermediates is semi-automatic with proven

technology. The process requires supervision of experienced in-charge to control

yield and quality. No specialized know-how is required for the process. The input mix

is standardized and the output is standardized in weight.

To supervise day to day production process, the company will appoint technically

qualified and experienced persons having relevant experience in the line of

manufacturing of Bulk drug intermediates.

The Unit will have well experienced, skilled and dedicated work force.

Selling and Marketing Arrangement:

The Company, by virtue of its well experienced directors in the field of Bulk drugs

and pharmaceuticals, has well established market connections. The company

directors have good relations with top executives of many reputed pharma

companies and traders by virtue of which fresh orders can be organized at any given

time. Many recognized companies assured their orders to the company and many

more orders are expected based on the completion of facility and regular production.

Our products and their intermediates are used in many organizations, and it is

proposed to enter into long term contract with these organizations. To name a few

S. No Name of the Company/ trader 1 M/s. Emmennar Bio-Tech Pvt Ltd, Visakhapatnam. 2 M/s. Andhra Organics Limited –Pydibhimavaram,

Srikakulam District. 3. M/s. Virchow Petrochemicals Private Limited. 4. M/s. Covalant Laboratories Limited. 5 M/s. Saraca Laboratories Limited

Also, the Company proposes to have its own market network by appointing experienced marketing staff and dealers to sell the products. The company also approached many prospective buyers who have assured to give their requirement on conversion basis (Buy back arrangements) so that the company can have both self products and conversion market also. This will enable the company to have better control in plant operation, better market and financial flexibility.


78

SWOT Analysis Strengths:

• The Promoters are technically qualified, well experienced and financially sound besides possessing the required managerial competence and business skills to make proposed project and successful and profitable venture.

• Procurement of raw material is very easy, since Hyderabad and Bangalore

being major pharma production center in India.

• The Project is located near Hyderabad and Mumbai the Pharma hub of India.

• Well Developed Industry with Strong Manufacturing Base and present industry conditions are favorable.

• Access to pool highly trained scientists.

• Competencies in technology and process development

• Cost competitiveness in Global Market. Opportunities:

• Significant Export potential

• Licensing deals with MNCs

• Marketing alliances to sell MNC products in domestic market

• Contract manufacturing arrangements with MNCs

• Supply of generic drugs to developed markets Threats:

• Product patient regime poses serious challenge to domestic industry unless it invests in research and development.

• R&D efforts of Indian pharmaceutical companies hampered by lack of

enabling regulatory requirement. For instance, restrictions of animal testing outdated patent office.


79

• Drug Price Control Order puts unrealistic ceilings on product prices and profitability and prevents pharmaceutical companies from generating investible surplus.

• Lowering of tariff protection

• The new MRP based excise duty regime threatens the existence of many

small scale pharma units, especially in the states of Andhra Pradesh and Maharashtra that were involved in contract manufacturing for the larger, established players. These companies are now shifting their manufacturing from these states to states like Himachal Pradesh, Uttaranchal that enjoy tax holidays.

Risk Factors and mitigation 1. The company is promoted by first generation entrepreneurs Though the Company is promoted by first generation entrepreneurs, the Promoters are technically qualified, well experienced and financially sound besides possessing the required managerial competence and business skills to make proposed project a successful and profitable venture. Further the Company has identified and proposes to appoint professionals in key areas of Production, Research & Development, marketing, logistics and Finance. 2. The Company operates in a globally competitive business environment. Growing competition may force the company to reduce the prices of its products and services, which may reduce its revenues and margins and/or decrease its market share, either of which could have a materially adverse effect on its business, financial condition and results of operations. The company aims to keep abreast with the dynamic business scenario and will broad-based its product mix. The Company, continuous R&D activities, will develop better process technology, improved process yield, sourcing of raw material at competitive price and development of new products/processes. 3. The prices of Raw Material/solvent consumed by the Company are susceptible to volatility. A majority of these raw materials are basic chemical, the demand for which is not dependent on demand by pharmaceutical industry. The other industries, which are generally much bigger consumer of such chemicals, tend to determine market prices of such basic chemicals; such volatility may affect company’s profitability. The raw materials consumed are general chemicals and are available in India as well as in many countries around the world at competitive prices. The company does not see any problem in procuring the raw material/solvent at competitive prices.


80

4. Expansions: Enhancement in production capacity by primary/main producers in our country may drive the industry into excess production. All the major producers are having plans to go for expansion in the production facilities. The other primary producers are having high fixed overheads and their market is through dealers. But the Company is having established market connections

M/s. Emmennar Pharma Pvt. Ltd., Unit – III. · 2014. 1. 29. · M/s. Emmennar Pharma Pvt. Ltd.,...

Documents

Transcript of M/s. Emmennar Pharma Pvt. Ltd., Unit – III. · 2014. 1. 29. · M/s. Emmennar Pharma Pvt. Ltd.,...